Advisory - Pradaxa (dabigatran, previously called Pradax): not to be used in patients with artificial heart valves

Health Canada is advising health care professionals and the public that,
based on new information, the blood-thinning drug Pradaxa is not to be
used in patients with artificial heart valves (also known as prosthetic
heart valves) due to the risk of strokes, bleeding, heart attacks, and
blood clots forming on the artificial heart valves.

Who is affected:

Patients who are taking Pradaxa and have an artificial heart valve.

What patients should do:

If you are taking Pradaxa and have had an artificial heart valve
replacement, talk to your health care professional as soon as possible
to determine the most appropriate alternative treatment.

Do not stop using Pradaxa or other anticoagulants without guidance from
your health care professional. Stopping anticoagulants suddenly may
increase your risk of blood clots or a stroke.

Report any adverse reactions (side-effects) you may have experienced to
your health care professional.

What health care professionals should do:

Pradaxa is contraindicated now in patients with artificial heart valves
requiring anticoagulant treatment due to their valvular status.

Consider promptly transitioning any patient with an artificial heart
valve who is taking Pradaxa to another appropriate anticoagulant
medication.

Please note that the information in the associated Notice to Hospitals
supplements the information on this issue (dated December 21, 2012)
provided by Boehringer Ingelheim (Canada) Ltd., the manufacturer of
Pradaxa.

What Health Canada is doing:

Health Canada is working with the manufacturer of Pradaxa, Boehringer
Ingelheim (Canada) Ltd., to update the Canadian Product Monograph for
Pradaxa to strengthen the present warning that the drug should not be
prescribed to patients with artificial heart valves. The Product
Monograph for Pradaxa currently recommends against the use of Pradaxa
in patients with artificial heart valves.

Background:

As per the Canadian Product Monograph, Pradaxa (dabigatran etexilate) is
approved for the prevention of blood clots in patients who have
undergone hip replacement or total knee replacement surgery, and for
the prevention of stroke and blood clots in the body in patients with
atrial fibrillation (irregular heart beat) in whom a medication to
prevent blood clotting is considered appropriate.

A recent European clinical trial involving patients with a type of
artificial heart valve was terminated early due to significantly more
adverse events for patients using Pradaxa.

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